5019 – DotDiver BiermAK

Intended Purpose

The DotDiver BiermAK is a qualitative dot immunoassay for the determination of IgG antibodies against intrinsic factor and antigens of parietal cells in human serum. The DotDiver BiermAK is intended as an aid in the diagnosis of chronic atrophic gastritis in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

The essential role played by intrinsic factor (IF), a glycoprotein containing sialic acid, in the absorption of vitamin B12 (extrinsic factor) in the digestive tract, makes it an important serological marker in the diagnosis of diseases associated with deficiency in vitamin B12, e.g. that may lead to the development of Biermer’s anemia (pernicious anemia).

The main antigen of autoantibodies to parietal cells is the membrane H⁺/K⁺ ATPase transporting H⁺ into the stomach. Antibodies to this ATPase are a sensitive marker for type A gastritis and will be found in 80-90% of such patients. Autoantibodies to intrinsic factor are detected mainly in patients with pernicious anemia associated with gastritis and are pathognomonic for this clinical picture.